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PP96 Joint Clinical Assessments – Implementation And Lessons For The Next Stage Of EU HTA
- Dima Samaha, Max Newton, Eliana Tavares, Robert Kruger, Paula Szawara, Anke van Engen
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S72
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- Article
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Introduction
The European Network for Health Technology Assessment (EUnetHTA) was a voluntary cross-border initiative on HTA harmonization established by European Commission in 2005. Between 2016-2021, EUnetHTA completed 56 Joint Assessments (28 drugs; 28 other technologies) including 14 reviews of COVID treatments.
MethodsWe conducted a review of the 14 EUnetHTA joint assessment reports of drugs in non-COVID 19 indications. We cross-referenced recommendations with national guidance in 30 member countries (including UK) and conducted an analysis of time to national assessment, choice of comparator, direct reference to EUnetHTA assessment, and time to reimbursement decision.
ResultsSix products in oncology, 2 in endocrine and metabolic diseases, 2 in infectious and parasitic diseases, and cardiovascular, digestive system, eye disorders and central nervous system (one each) were identified. On average, EUnetHTA published its recommendation 52 days after market authorization for oncology products and 33 days for non- oncology products. EUnetHTA recommendations considered on average 4 comparators (range 1-8) as part of the assessment. All of the 6 oncology products have been assessed by national HTA bodies, however uptake was low with an average of 5 reports referencing the EUnetHTA report. Similarly for the non-oncology products assessed only 3 of 30 HTA bodies cite the EUnetHTA report. Citing HTA bodies were: AETSA (Spain), HAS (France), INFARMED (Portugal), NoMA (Norway), and TLV (Sweden). There was no clear reduction in the time to reimbursement for these products in these markets.
ConclusionsAccording to EUnetHTA, there has been an increased use and dissemination of joint assessment reports since 2016. Our analysis shows that the level of implementation across countries is heterogeneous despite publication of the EUnetHTA reports shortly after market authorization. The future the EU HTA will depend on the timeliness, rigor and transparency of joint clinical assessment reports and improved uptake of these reports at a national level.
5 - The Medical Device Sector
- Edited by Lawton Robert Burns, Wharton School, University of Pennsylvania
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- Book:
- The Business of Healthcare Innovation
- Published online:
- 24 February 2020
- Print publication:
- 12 March 2020, pp 321-397
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Summary
Medical devices and medical technology, with worldwide revenues of roughly $330 billion, comprise an important segment within healthcare. This broad set of products, ranging from extraordinarily complex implantable defibrillators to metal mesh stents to hip and knee implants, have truly advanced the practice of medicine and represent life-saving therapies to patients in need. Growth, in recent years, while slower than that of the 1990s when several entirely new therapeutic categories emerged, continues at a good pace. The industry is increasingly dominated by large companies such as Medtronic, Abbott, Johnson & Johnson, and Stryker which offer a broad mix of technologies in multiple anatomies and diseases. In as much as structural developments, including reimbursement and the containment of healthcare costs, they have made it more difficult for single product/single anatomy companies to flourish. Those that provide truly innovative products that are treatment-altering can succeed and remain independent. Indeed, there exist several examples – in areas such as diabetes, heart failure, and neurological diseases. Furthermore, the industry remains highly profitable – companies on average enjoy operating margins in the mid-twenties, considerably higher than nearly every other industry. We anticipate continued growth for the sector as devices and technology play an expanded role in healthcare. Of the US $3.6 trillion healthcare spend, medical technology represents less than 5 percent on a revenue basis.
6 - The medical device sector
- Edited by Lawton Robert Burns, University of Philadelphia
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- Book:
- The Business of Healthcare Innovation
- Published online:
- 05 November 2012
- Print publication:
- 26 July 2012, pp 376-450
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Summary
Introduction
The medical device sector, an attractive and profitable business, has grown and matured to become a large and established part of the healthcare industry. The broad set of products encompassed by this category span all physician specialties, touch every conceivable anatomy, and are applied to nearly every medical procedure. They range from the simplest surgical staples and sutures to complex electronic implantable devices that essentially perform the practice of an electrophysiologist, monitoring heart function and delivering intelligent electrical therapy. This sector experienced extraordinary growth during the last several decades as technological developments provided medical practitioners with life-saving and life-improving tools, implants and equipment that have changed the very practice of medicine. It was the golden age of medical products. Companies were rewarded mightily for products that unleash value within the clinic by improving outcomes and saving precious time. These products conveyed benefits that were “built in” at the factory and later realized in the clinical setting during medical–surgical procedures that were heavily labor and resource intensive. These benefits were realized by millions of patients worldwide who experienced better outcomes in an acute setting and, in the case of implanted products, enjoyed those benefits throughout their lives.
Medical devices might have been considered a cottage industry as recently as a few decades ago, but after experiencing consistent growth at mid- to high single-digit rates the sector has reached $235 billion in worldwide revenues in 2009 (see Figure 6.1). This total is divided between medical devices, accounting for approximately $146 billion in revenues, and commodity supplies, at $89 billion.
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